Healthcare Innovation Cycle for "Biomarker Diagnostic" Solutions

Biomarker Diagnostics is a broad term for diagnostics that utilize biomarkers. Tracking data has been added that shows an example of an early stage team at risk due to a focus on technology and clinical to the exclusion of Market/Business and Regulatory issues. Select any Maturity Level to see the core Requirements or select the Requirements themselves to see a description of what is involved in completing a requirement and curated resources.

Note:To access the Resources that describe each Deliverable, use the Sign-in button above to create an account and then click on the Deliverable or the Innovation Maturity Level to see all Deliverables at that level and click on the one of interest.

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Requirement

Preliminary Regulatory Pathway

The regulatory pathway you expect will be used to approve your solution.
The regulatory pathway that your solution must follow will have a tremendous impact on the development cost and time it takes to reach patients. Understanding that pathway early may allow you to adjust the solution or application to find an easier path to the initial product. It also helps you understand the type of information you will need to collect as your development effort proceeds.
Web sites of regulatory agencies, discussions with regulatory experts, observations/discussions with companies/managers who have successfully gotten regulatory approvals for similar solutions. The process will also typically involve a consideration of reduced product claims that may provide an expedited pathway to market. If US focused, follow the FDA’s guidance to determine the most appropriate pathway. Consider if market introduction is best through a different regulatory body – but only those such as EU and Australia that are recognized as having robust systems.

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Resource Type
Regions/Markets